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NCT04725097 Clinical Trial

A Study to Evaluate Rapid Throughput Screening for Human COVID-19 Infection

Covid19 Clinical Trial

Official title:
Rapid Throughput Screening for Human COVID-19 Infection: A ECG Study

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04725097
Other study ID # 20-011415
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date December 10, 2020
Est. completion date June 3, 2021

Study information
Verified date September 2021
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to assess the ability of an artificial intelligence smartphone-enabled point of care ECG to detect COVID-19.

Recruitment information / eligibility
Status Terminated
Enrollment 2821
Est. completion date June 3, 2021
Est. primary completion date June 3, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 89 Years
Eligibility Inclusion Criteria: - Adult males and females age 18 or greater. - Undergoing COVID-19 testing by PCR. - Willing and able to provide informed consent. - Pregnant females (minimal risk study, no risk from ECG). Exclusion Criteria: - Unwilling or unable to provide informed consent.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
India Sri Jayadeva Bengaluru Karnataka
India King Edward Memorial Hospital Mumbai Maharashtra
Spain Gregorio Marañon Hospital Madrid
United Kingdom Imperial College London England
United States Hackensack Meridian Health Hackensack New Jersey
United States Mayo Clinic Jacksonville Florida
United States Mayo Clinic Phoenix Arizona
United States Mayo Clinic Rochester Minnesota
United States LSUHSC Shreveport Shreveport Louisiana
United States Henry Ford Health System West Bloomfield Michigan

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Countries where clinical trial is conducted

United States,  India,  Spain,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary COVID 19 Detection Determine the safety and feasibility of the POC AI-ECG's ability to detect active SARS-Cov-2 infection in humans. One time screening within 4 hours of PCR test
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